Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Anterior Nares Nasal Samples For Point-of-Care (POC) Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,081
- 试验地点
- 2
- 主要终点
- Performance evaluation of the LumiraDx SARS-CoV-2 & Flu A/B in point of care settings
研究概览
简要总结
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 & Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.
详细描述
This will be a prospective study at point of care sites in the United States for the clinical validation of the LumiraDx SARS-CoV-2 & Flu A/B test for the differential detection of the SARS-CoV-2, and influenza A & B using anterior nasal samples. Up to 1,500 or more symptomatic subjects who are currently experiencing symptoms associated with COVID-19 and Influenza A & B may be enrolled.
The samples are obtained from each subject using standard collection methods and are processed and tested by untrained operators without laboratory training and with no prior experience using the candidate test.
The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the LumiraDx SARS-CoV-2 & Flu A/B test for the qualitative and differential detection of SARS-CoV-2, Influenza A & B virus antigen using anterior nares samples collected by a healthcare professional, compared to a 510(k) cleared or Emergency Use Authorized (EUA) high-sensitivity reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 and a 510(k) cleared Influenza A/B test.
The secondary objective is to assess the usability and user accuracy/performance around limit of detection (LoD) of the investigational test using a questionnaire and accuracy study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to study enrollment.
- •Male or female aged 2 years of age or older
- •Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
排除标准
- •Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented.
- •Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- •Subject is not able to tolerate sample collection.
- •Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- •Subjects undergoing treatment currently and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-
- •Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
- •Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to study sample collection.
- •Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
结局指标
主要结局
Performance evaluation of the LumiraDx SARS-CoV-2 & Flu A/B in point of care settings
时间窗: 6 months
Evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B test in detecting and differentiating SARS-CoV-2, influenza A and influenza B in fresh nasal swab specimens from symptomatic patients. Performance will be evaluated by use of statistical analysis techniques to assess negative and positive percent agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.
次要结局
- Validation of the LumiraDx SARS-CoV-2 & Flu A/B for use by intended users(2 months)